FDA.reportPublic FDA data

tacrolimus 4 MG 24HR Extended Release Tablet

RxCUI
1664434
RxNorm name
tacrolimus 4 MG 24HR Extended Release Tablet
Display name
tacrolimus 4 MG 24HR Extended Release Tablet
Full name
tacrolimus 4 MG 24HR Extended Release Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Envarsus XRTACROLIMUSVeloxis Pharmaceuticals, Incde2315b0-6344-43ac-9aea-3e3b68d828e72025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1664434

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
de2315b0-6344-43ac-9aea-3e3b68d828e7tacrolimus 4 MG 24HR Extended Release Tablet [PSN] · 24 HR tacrolimus 4 MG Extended Release Oral Tablet [SCD] · tacrolimus 4 MG (as anhydrous tacrolimus) 24HR Extended Release Tablet [SY]316These highlights do not include all the information needed to use ENVARSUS XR ® safely and effectively. See full prescribing information for ENVARSUS XR. ENVARSUS XR ® (tacrolimus extended-release tablets), for oral use Initial U.S. Approval: 199420250226